Washington Editor

WASHINGTON - The Bush administration's proposed 2009 fiscal year budget for the FDA includes not only a 5.7 percent increase but a plan to seek authority to allow the agency to approve abbreviated applications for certain biologic products, or follow-on biologics.

The administration is seeking $2.4 billion for the FDA for fiscal year 2009 as part of its record $3 trillion budget proposal unveiled Monday.

The FDA's budget includes $628 million in industry user fees, an increase of $79 million over the current fiscal year. The lion's share of that increase is for the prescription drug user fee program, Robert Miller, deputy director of budget formulation and presentation in the FDA's Office of Management, said Monday during a media briefing.

About $35 million of the user fees will be directed specifically to drug safety activities, he told reporters.

Miller noted that a portion of the proposed user fee budget will go toward reviewing certain television advertisements for prescription drugs, a program that was created under the FDA Amendments Act of 2007, which was enacted in September.

Because Congress failed to appropriate the initial funds necessary to get the program off the ground under the 2008 budget, the FDA suspended the program for the current year. (See BioWorld Today, Jan. 22, 2008.)

However, Miller said, the FDA is reproposing the funds in the 2009 budget and will work with lawmakers to ensure that the agency can operate the commercial review program.

As part of the budget package, the administration said it is seeking regulatory authority for the FDA to approve follow-on biologics, also called biosimilars or biogenerics, which would be financed through user fees.

Currently, no such approval pathway exists for follow-on biologics.

The House and the Senate both introduced follow-on biologics legislation in 2007, with the Senate's bill moving the furthest by achieving passage by the Health, Education, Labor and Pensions Committee. Lawmakers have pledged to move the legislation forward in 2008.

Regulators were unable to provide details during Monday's media briefing about the administration's plan to use user fees to support follow-on biologic approvals.

"We don't have the specifics yet," said John Dyer, the FDA's deputy commissioner for operations and chief operating officer.

The agency said it is drafting a legislative proposal that will include the "necessary provisions to ensure the safety and effectiveness of these biologic products for patients."

In a document titled "Other Legislative Items" that is part of the White House fiscal year 2009 budget, the administration said the follow-on biologic legislative proposal would include a "predictable and public guidance process for licensing follow-on protein products" under the Public Health Service Act.

"The proposal will prescribe the type of data required for FDA to review applications for follow-on protein products and will require labeling for the safety concerns related to the interchangeability of these products," the Bush administration said.

The proposal also will include "adequate intellectual property protections to preserve continued robust research into new and innovative life-saving medications," the document stated.

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), said he was "pleased" that the administration included language in the budget proposal calling for a pathway to approve follow-on biologics.

"BIO strongly believes that the FDA should have a pathway for the approval of follow-on biologics, which protects patient safety and promotes continued innovation," Greenwood said in a statement.

"The creation of a pathway for follow-on biologics is a top legislative priority for BIO, and we are meeting with members of the House and Senate to encourage them to consider and pass follow-on biologics legislation this session," he added.

Kathleen Jaeger, CEO of the Generic Pharmaceutical Association (GPhA), also praised the budget plan's follow-on biologics measure.

"We welcome the news that the administration has endorsed the fact that FDA has the scientific expertise to establish a safe and workable regulatory approval pathway for biogenerics," Jaeger said in a statement. She called on the Bush administration to require the FDA to "provide timely access" to follow-on biologics.

"A pathway filled with roadblocks to access, including excessive market exclusivity provisions, is an empty promise for countless patients who need these affordable life-saving medicines," Jaeger contended.

She noted that the FDA budget package includes a proposal to allow the agency to collect $16.6 million in user fees from makers of generic drugs to support the review process for those medications.

The generic drug user fee program would provide "urgent" increased resources necessary to respond to the growing number of abbreviated new drug applications, the FDA said.

Regulators first sought approval of the program last year under the Bush administration's 2008 budget.

Not proceeding with the user fees for the generic drug review program will result in "the inability to capture significant savings from generic drug use," the FDA argued, adding that government health care programs rely on the availability of generic drugs to hold down costs.

GPhA supports the generic drug user fee program, Jaeger said. But, she added, "to truly benefit consumers, the program must be effective and remove longstanding barriers to access."

Although the White House is proposing a 5.7 percent increase in the FDA's budget, some consumer groups and lawmakers called the raise insufficient to improve the embattled agency.

"The amount in the administration's proposed budget is not only inadequate, it is barely half of what FDA needs just to keep pace with inflation," said William Hubbard, a former FDA deputy commissioner and a member of the Alliance for a Stronger FDA, a 170-member organization that has pushed for increased funding for the agency.

"The FDA's ability to fulfill its mission could be in serious jeopardy if additional increases aren't enacted," Hubbard said. "This proposed budget would likely force the agency into further staff decreases, at a time when it is urgent to increase staff."

Lawmakers Reps. Henry A. Waxman (D-Calif.), John D. Dingell (D-Mich.), Bart Stupak (D-Mich.) and Frank Pallone Jr. (D-N.J.) argued that the proposed FDA budget "barely covers the cost of inflation and continues the trend of the inadequate budgets of previous years that have led to the current crisis at the agency."

The congressmen called on the FDA's Science Board Subcommittee on Science and Technology to assess whether the FDA budget package would provide the resources needed to correct the serious deficiencies revealed late last year in a report authored by the panel.

In the report, the subcommittee criticized the FDA for allowing its scientific base to erode and called the agency's scientific organizational structure weak.

Although the subcommittee recently disbanded and no longer exists as a formal entity, the lawmakers urged the group to reconvene to review the Bush administration's FDA budget proposal.

"We want to ensure that funding for FDA is sufficient to permit the agency to fulfill its many regulatory responsibilities," the lawmakers said in a letter to the group.